Actively Recruiting
Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-09-19
11
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA/CD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.
CONDITIONS
Official Title
Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 years or older.
- Diagnosed with refractory B-cell-related pediatric rheumatic diseases including juvenile dermatomyositis, polyarticular juvenile idiopathic arthritis, systemic sclerosis, or primary Sjogren's syndrome.
- For juvenile dermatomyositis, must meet Bohan and Peter criteria and be intolerant or unresponsive to glucocorticoids and at least 2 immunosuppressants with hormone therapy for at least 6 months, or have rapid disease progression or specific clinical features.
- Diagnosis of polyarticular juvenile idiopathic arthritis with active disease after at least 6 months of DMARDS treatment and stable dose for 12 weeks.
- Diagnosis of systemic sclerosis with intractable disease unresponsive to glucocorticoids and immunomodulators for more than 3 months or rapid progression, and Modified Rodnan Skin Score (mRSS) 15 points or higher.
- Diagnosis of primary Sjogren's syndrome with intolerance or insufficient response to glucocorticoids and at least two immunosuppressants for at least 6 months, plus specific clinical features and positive anti-SSA/Ro antibody.
- Positive CD19 expression in peripheral blood B cells with B cells greater than 5 per microliter.
- No prior CAR-T treatment or relapse/poor response after previous CD19-targeted CAR-T.
- Normal important organ functions including cardiac, renal, liver, and lung functions.
- Eligible for leukapheresis or intravenous blood collection without contraindications.
- Negative urine pregnancy test and agreement to use contraception for childbearing age participants.
- Signed informed consent by patient or guardian after understanding the study purpose and procedures.
You will not qualify if you...
- Severe major organ involvement related to the primary disease, such as severe pulmonary hypertension.
- Primary or severe secondary immunodeficiency not corrected.
- Serious, active, or uncontrollable infections including active or latent tuberculosis and active viral hepatitis.
- Active malignant disease or diagnosed malignant tumor except cured skin basal cell carcinoma.
- Congenital heart disease or severe arrhythmias, large pericardial effusion, serious myocarditis, or unstable vital signs requiring blood pressure medication.
- Other diseases requiring long-term glucocorticoids or immunosuppressants.
- Recent solid organ or hematopoietic stem cell transplantation within 3 months or recent acute graft-versus-host disease.
- Positive for hepatitis B surface antigen or core antibody with elevated viral load, hepatitis C antibody with elevated viral load, HIV antibodies, or syphilis.
- Received live vaccine within 4 weeks before screening.
- Positive pregnancy test.
- Any condition deemed inappropriate for study participation by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
M
Meiping Lu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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